On February 7, 2018 Roivant Sciences and ArQule, Inc. (NASDAQ: ARQL) reported the initiation of a collaboration to pursue the development of derazantinib, a pan-FGFR (fibroblast growth factor receptor) inhibitor, in Greater China (Press release, ArQule, FEB 7, 2018, View Source [SID1234523772]). As part of the collaboration, ArQule has granted a Roivant subsidiary an exclusive license to develop and commercialize derazantinib in the People’s Republic of China, Hong Kong, Macau, and Taiwan. Deal terms include an upfront payment to ArQule of $3 million and an additional $2.5 million development milestone within the first year. ArQule is also eligible for regulatory and commercial milestones and royalties on future sales of derazantinib in Greater China.

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ArQule is currently conducting a registrational trial for derazantinib in the United States and Europe as a potential treatment for intrahepatic cholangiocarcinoma (iCCA), a form of biliary tract cancer. The People’s Republic of China has one of the world’s highest incidences of iCCA, where it is the second most common form of liver cancer. Roivant intends to pursue the development of derazantinib in China for the treatment of iCCA while also pursuing further development in other tumor types with high rates of FGFR mutation.

"Intrahepatic cholangiocarcinoma is a devastating form of cancer, and there are no approved therapies globally," said Vivek Ramaswamy, Founder and CEO of Roivant Sciences. "The prevalence of this disease is exceptionally high in China and we will do our part to further the development of derazantinib in that region."

"We are pleased with Roivant’s commitment to develop derazantinib in China, where the need for novel therapies is so pressing," said Paolo Pucci, CEO of ArQule. "We share their commitment to ensuring broad geographic access to new medicines, and we look forward to developing derazantinib in iCCA and other FGFR-driven cancers."

About Derazantinib

Derazantinib is a potent, orally administered inhibitor of the fibroblast growth factor receptor (FGFR) family, a key driver of cell proliferation, differentiation, and migration. In a Phase 1/2 study in patients with iCCA harboring FGFR2 gene fusions, treatment with derazantinib resulted in an objective response rate of 21%, nearly 3 times higher than standard-of-care chemotherapy. ArQule is currently conducting a registrational study with derazantinib in patients with FGFR2 fusion-positive second-line iCCA. The open-label single-arm trial is recruiting in both the United States and Europe with objective response rate as the primary endpoint. More information on that program is available here.

About Intrahepatic Cholangiocarcinoma

Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (HCC).1 Depending on the anatomic location, CCA is classified as intrahepatic (iCCA), perihilar (pCCA), and extrahepatic (eCCA). iCCA originates from the intrahepatic biliary ductal system and forms an intrahepatic mass. iCCA is an aggressive cancer, with a median 5-year survival rate of 15% for patients diagnosed with early-stage disease.2 In China, the incidence of cholangiocarcinoma is more than 7 cases per 100,000 people, and the majority of cases are intrahepatic.3

On February 7, 2018 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, reported that company management will participate in fireside chats at two upcoming conferences (Press release, Xencor, FEB 7, 2018, View Source [SID1234524358]):

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Leerink Partners 7th Annual Global Healthcare Conference
Date: Wednesday, February 14, 2018
Time: 1:00 p.m. ET
Location: New York, NY
RBC Capital Markets 2018 Global Healthcare Conference
Date: Wednesday, February 21, 2018
Time: 10:30 a.m. ET
Location: New York, NY

Live webcasts of both events will be available under "Events & Presentations" in the Investors section of the Company’s website located at View Source A replay of the presentations will be posted on the Xencor website approximately one hour after the live events and will be available for 90 days following the presentations.

On February 7, 2018 BioTime, Inc. (NYSE American: BTX), a late-stage, clinical biotechnology company developing and commercializing products addressing degenerative diseases, reported that Adi Mohanty, Co-Chief Executive Officer of BioTime, will participate in the BIO CEO and Investor Conference, on February 12th and 13th 2018, at the New York Marriott Marquis (Press release, BioTime, FEB 7, 2018, View Source;p=RssLanding&cat=news&id=2330855 [SID1234523773]).

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The BIO CEO and Investor Conference is one of the largest investor conferences focused on established and emerging publicly traded and select private biotech companies. One-on-one meetings with Mr. Mohanty can be arranged by scheduling through the BIO CEO and Investor Conference 1×1 desk or by contacting David Nakasone, Director of Investor Relations at BioTime, at 510-871-4188 or [email protected].

On February 7, 2018 The NIPRO Corporation (TSE: 8086) and TC BioPharm Ltd (TCB), reported that they have formed a strategic collaboration to co-develop a novel immunotherapy product using TCB’s safe CAR-T platform, based on unique properties of modified gamma delta (γδ) T cells to selectively target cancer whilst leaving healthy cells untouched (Press release, TC Biopharm, FEB 7, 2018, http://www.tcbiopharm.com/index.php/component/content/article/96 [SID1234524275]). TCB intends to use this novel platform to develop new CAR-based immunotherapies, with the aim of treating a broad range of cancers and major viral disease.

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"TCB’s world-class GMP-compliant manufacturing facility and experienced in-house clinical team will allow us to leverage patient treatment at established cancer therapy centers throughout Europe", said TCB’s Chief Operating Officer, Angela Scott, "since commencing operations in 2014, we have treated numerous cancer patients successfully with unmodified gamma-delta T cells and built sufficient infrastructure to progress our innovative proprietary next-generation CAR-T towards phase I studies during 2018."

The NIPRO Corporation will provide non-dilutive funds in the form of up-front fees, milestone payments and research-support to progress elements of TCB’s CAR-T program to clinical studies. NIPRO cash will provide the Osaka-based company with an exclusive right to sell, and distribute CAR-T product worldwide.

TCB and NIPRO will co-develop an autologous gamma-delta CAR-T therapy directed against CD19, which is expressed in several B cell tumors such as multiple myeloma and lymphoma. Preclinical studies developing the product will be supported by a Scottish Enterprise ‘seek-and-solve’ grant which will provide £2.7m of additional non-dilutive funding. Commenting on both the grant and collaboration, Jim Watson, director of Innovation & Enterprise Services at Scottish Enterprise, said, "This particular grant is designed to encourage investment in R&D and inspire Scottish companies to partner with international players to expand market reach, it’s fantastic to see a pre-revenue company like TCB collaborating with NIPRO. TCB’s strong international mindset will help the company reap benefits of this collaboration – both in terms of financial support and the market knowledge that NIPRO brings to the table. The Seek and Solve project will allow TCB to accelerate route to market, meaning potentially quicker returns for the Scottish economy, helping establish TCB as a global leader in cancer-specific cell therapies."

TCB’s proprietary ImmuniCAR platform uses the innate ability of gamma-delta T cells to target cancer, this has allowed the Company develop a wide-range of innovative safe therapies designed to treat a variety of tumours without toxic side-effects seen in many current CAR-T products. NIPRO’s Managing Director, Toshiaki Masuda, said, "The collaboration with TC Biopharm – who has stand-alone technology in developing CAR-T products; and NIPRO – an experienced company in manufacturing cell culture products, will establish the safe and innovative cancer therapeutics for practical use in the global market."

Head of the Department of Oncology at the University of Oxford, Professor Mark Middleton noted that, "the combination of gamma delta and CAR T cell therapy gives us the opportunity to test this promising new treatment in patients for the first time.’ He added that, ‘those of us who treat solid tumors have followed use of CAR T cells in hematological malignancy with great interest, this exciting collaboration between TCB and NIPRO has potential to overcome safety challenges when developing such treatments in patients with solid tumors".

The collaboration with NIPRO is TCB’s first major pharma deal centred in Asia, and represents a strong endorsement of the therapeutic approach. Remarking on this significant milestone for the Company, Chief Executive Dr Michael Leek iterated that, "This commercial collaboration represents the cutting-edge of cell-based immunotherapy, providing clinicians and cancer patients access to next-generation, safe, innovative oncology products, we are privileged to be working alongside the NIPRO Corporation as they continue to build a formidable presence in the regenerative medicine sector ".

Chief Business Officer Dr Artin Moussavi added, "TCB has been very active over the last 12 months raising over $35m cash, sealing long-term commercial relationships with a potential combined pre-market income over $1bn. The NIPRO collaboration is our latest such deal, representing a joint-effort to build a significant immune-oncology business in Japan and Asia".

Myriad Genetics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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